AstraZeneca’s Breztri approved in the US for asthma, becoming the first and only single-inhaler triple therapy for patients aged 12 and older

AstraZeneca has secured FDA approval for Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) as a maintenance treatment for asthma in adult and paediatric patients aged 12 and older, marking the therapy’s second approved indication following its 2020 approval for chronic obstructive pulmonary disease. Breztri combines an inhaled corticosteroid and long-acting beta2-agonist with a long-acting muscarinic antagonist in a single inhaler, and is now the only triple therapy available for asthma in this age group.

Asthma remains a significant unmet need in the United States, where 27 million people live with the condition. Around half of those patients remain inadequately controlled on existing dual therapies, leaving them vulnerable to airway inflammation and bronchoconstriction that causes wheezing, breathlessness, chest tightness and potentially life-threatening exacerbations. Nearly 10 million asthma attacks still occur in the US each year.

The FDA approval is based on efficacy and safety data from the Phase III KALOS and LOGOS trials, which evaluated Breztri across a broad asthma population including patients with and without recent exacerbations. Both trials demonstrated statistically significant and clinically meaningful improvements in lung function versus dual ICS/LABA therapy. A key secondary endpoint further showed a significant improvement in lung function within just five minutes of the first dose, pointing to a notably rapid onset of action. No new safety or tolerability signals were identified in either trial. Full results were published in the Lancet Respiratory Medicine in February 2026.

Njira Lugogo, Clinical Professor of Pulmonary and Critical Care Medicine at the University of Michigan and a trial investigator, described the approval as a turning point for patients who have not been well served by current options: “Despite the availability of dual maintenance therapy, many patients are still at risk for exacerbations and experience daily breathing difficulties, reduced lung function and the ongoing fear of worsening symptoms. The FDA approval of Breztri as the only maintenance triple therapy for people with asthma 12 years of age and older marks a pivotal moment in helping those living with this debilitating disease breathe better, sooner.”

Ruud Dobber, AstraZeneca’s Executive Vice President for its BioPharmaceuticals Business Unit, underlined both the commercial momentum behind Breztri and the significance of expanding into asthma: “As the fastest growing fixed-dose triple-combination therapy in COPD, Breztri is already improving outcomes for people suffering with COPD, and we are proud to extend its benefits to asthma patients. The FDA’s approval of Breztri in asthma demonstrates how our innovative science continues to bring new solutions for patients with respiratory diseases.”

Breztri was prescribed to more than 6.8 million patients globally in 2025 for COPD, where it is approved in 90 countries including the US, EU, China and Japan. Regulatory filings for the new asthma indication are currently under review in those same major markets. Breztri is a maintenance therapy only and is not intended to provide relief from acute breathing problems or to replace a rescue inhaler.

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